[Federal Register Volume 85, Number 15 (Thursday, January 23, 2020)]
[Notices]
[Pages 3935-3937]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01075]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request Information Collection Request Title: Sickle 
Cell Disease Treatment Demonstration Regional Collaborative Program, 
OMB No. 0906-xxxx-New

AGENCY: Health Resources and Services Administration (HRSA), Department 
of Health and Human Services.

ACTION: Notice.

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SUMMARY: In compliance with the requirement for opportunity for public 
comment on proposed data collection projects of the Paperwork Reduction 
Act of 1995, HRSA announces plans to submit an Information Collection 
Request (ICR), described below, to the Office of Management and Budget 
(OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the 
public regarding the burden estimate, below, or any other aspect of the 
ICR.

DATES: Comments on this ICR should be received no later than March 23, 
2020.

ADDRESSES: Submit your comments to [email protected] or mail the HRSA 
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers 
Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
draft instruments, email [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301) 
443-1984.

SUPPLEMENTARY INFORMATION: When submitting comments or requesting 
information, please include the information request collection title 
for reference.
    Information Collection Request Title: Sickle Cell Disease Treatment 
Demonstration Regional Collaborative Program.
    OMB No.: 0906-xxxx-New.
    Abstract: The Sickle Cell Disease Treatment Demonstration Regional 
Collaborative Program (SCDTDRCP) was reauthorized and amended in 2018 
by the Sickle Cell Disease and Other Heritable Blood Disorders 
Research, Surveillance, Prevention, and Treatment Act (Pub. L. 115-
327), 42 U.S.C. 300b-5. The purpose of the proposed data collection is 
to monitor the progress of the SCDTDRCP in improving health outcomes in 
individuals living with sickle cell disease.
    The goals of the program are to improve health outcomes in 
individuals with sickle cell disease; reduce morbidity and mortality 
caused by

[[Page 3936]]

sickle cell disease; reduce the number of individuals with sickle cell 
receiving care only in emergency departments; and improve the quality 
of coordinated and comprehensive services to individuals with sickle 
cell and their families. The program funds five grantees to establish 
regional networks to provide leadership and support for regional and 
statewide activities in sickle cell disease. The grantees develop and 
establish systemic mechanisms to improve the treatment of sickle cell 
disease, by: (1) Increasing the number of providers treating 
individuals with sickle cell disease using the National Heart, Lung and 
Blood Institute (NHLBI) Evidence-Based Management of Sickle Cell 
Disease Expert Panel Report; (2) using tele-mentoring, telemedicine and 
other provider support strategies to increase the number of providers 
administering evidence-based sickle cell care; and (3) developing and 
implementing strategies to improve access to quality care with emphasis 
on individual and family engagement/partnership, adolescent transitions 
to adult life, and care in a medical home. The SCDTDRCP is designed to 
improve access to services for individuals with sickle cell disease, 
improve and expand patient and provider education, and improve and 
expand the continuity and coordination of service delivery for 
individuals with sickle cell disease and sickle cell trait. Per the 
statutory requirement, the data collected will be used to evaluate the 
program and will be published in a report to Congress.
    Need and Proposed Use of the Information: The purpose of the 
proposed data collection is to monitor the progress of the SCDTDRCP in 
improving care and health outcomes for individuals living with sickle 
cell disease/trait and monitor grantee progress in meeting the goals of 
the program. Each regional grantee will conduct one quality improvement 
initiative for hydroxyurea utilization among individuals with sickle 
cell disease. Grantees must conduct an additional quality improvement 
initiative on one of these topics: (1) Pneumococcal vaccinations, (2) 
Transcranial Doppler Ultrasound (TCD) screening, or (3) transition 
planning. Grantees are encouraged to conduct additional clinical 
outcome quality improvement (QI) initiatives according to their 
ability. The regional grantees will also survey providers annually to 
assess provider comfort with treating individuals with sickle cell 
disease, awareness of the guidelines and involvement in Project ECHO 
(Extension of Community Health Outcomes) and other program activities. 
Pursuant to 42 U.S.C. 300b-5(b)(3)(B), the Sickle Cell Disease 
Treatment Demonstration Regional Collaborative Program's National 
Coordinating Center (NCC) will work with the grantees to gather data 
and prepare a Report to Congress at the conclusion of the program. 
Additional information regarding the data collection activities is 
below:

Provider Survey

    Regional grantees will administer the Provider Survey annually to 
providers within their region. The Provider Survey is a 13 item 
questionnaire that collects information on the provider type, their 
utilization of telementoring, and aggregate de-identified patient-level 
data. The number of states participating within a region may range from 
5 to 17 states. Data from the Provider Survey will be aggregated by the 
regional grantee and submitted to the NCC.

Quality Improvement

    As part of the requirement for funding under the grant, each 
regional grantee is required to conduct at least two quality 
improvement initiatives within their region. All grantees are required 
to conduct a quality improvement initiative on increasing the use of 
hydroxyurea. Grantees must conduct an additional quality improvement 
initiative on one of these topics: (1) Pneumococcal vaccinations, (2) 
TCD screening, or (3) transition planning. Each regional grantee will 
collect QI data from participating providers and medical centers within 
their region and aggregate the data for submission to the NCC. Specific 
quality improvement data will be extracted from patients' charts 
quarterly, either manually or via electronic health records (EHR). This 
will require an initial set-up time in year 1 to develop data 
collection and reporting protocols for manual or electronic collection 
for the quality improvement project(s) that each regional grantee 
decides to measure. This initial set-up time has been included in the 
burden estimates listed in the chart.
    Likely Respondents: Providers who treat individuals with sickle 
cell disease will complete the Provider Survey. The five regional 
grantees will aggregate these data and submit to the NCC. The grantees 
will also aggregate data from medical record extraction for the quality 
improvement initiatives.
    Burden Statement: Burden in this context means the time expended by 
persons to generate, maintain, retain, disclose or provide the 
information requested. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purposes of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information; to search data sources; to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. The total annual burden hours estimated for 
this ICR are summarized in the tables below:

Provider Survey and QI Measures

                                       Total Annual Burden Estimate Hours
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                                                     Number of                        Average
                                     Number of     responses per       Total        burden per     Total  burden
            Form name               respondents     respondent    responses  per  response  (hrs/   hours  per
                                                     per year          year             yr)            year
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SCDTDP Provider Survey,                       70               1              70               1              70
 participant responses..........
SCDTDP..........................              50               4             200              22           4,400
QI Measures *...................
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    Total.......................             120  ..............             270  ..............           4,470
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* Note: Total burden hours per year shown represents the maximum number of estimated hours. Actual hours may be
  lower since many teams will not be assessing all four QI initiatives.


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    HRSA specifically requests comments on (1) the necessity and 
utility of the proposed information collection for the proper 
performance of the agency's functions, (2) the accuracy of the 
estimated burden, (3) ways to enhance the quality, utility, and clarity 
of the information to be collected, and (4) the use of automated 
collection techniques or other forms of information technology to 
minimize the information collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-01075 Filed 1-22-20; 8:45 am]
 BILLING CODE P